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Lupus NephritisPhase 2NCT05810948

A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)

A Phase 2 study testing efgartigimod IV in people with Lupus Nephritis, run by argenx at 31 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN). The study comprises an approximate 4-week screening period, a 24-week treatment period, and an 8-week follow- up period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lupus Nephritis
What is being tested?
efgartigimod IV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
73 participants
Where
31 sitesChina
Study dates
21 Feb 2023to 1 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 years when signing the informed consent form (ICF)
  • Capable of providing signed informed consent, and complying with protocol requirements
  • Diagnosis of SLE according to the Systemic Lupus Erythematosus International Collaborating Clinic (SLICC) 2012 classification criteria
  • Active, proliferative LN Class III or IV [excluding Class III (C), IV-S (C), and IV-G (C)], either with or without the presence of Class V using the 2003 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) criteria, proven by kidney biopsy within 6 months before randomization and confirmed by the central biopsy reading group
  • Require LN induction therapy (glucocorticoids and MMF/MPA) based on investigator's clinical judgment. Induction therapy may begin before screening but should be initiated within 60 days before randomization
  • Agree to use contraceptives consistent with local regulations. Full inclusion criteria can be found in the protocol

Who cannot join

  • Active or chronic infection requiring treatment
  • Any evidence of central nervous system lupus (including but not limited to seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis)
  • Currently on renal dialysis or expected to require dialysis during study period
  • Previous kidney transplantation or planned transplantation during study period
  • History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before randomization. The following cancers are not exclusionary: basal cell or squamous cell skin cancer; carcinoma in situ of the cervix; carcinoma in situ of the breast; incidental histological finding of prostate cancer
  • Heart failure due to Systemic Lupus Erythematodes, or any other severe cardiovascular involvement with safety concerns according to investigator's judgment
Show all 15Show fewer
  • Any other known autoimmune disease that would interfere with an accurate assessment of clinical symptoms of SLE/LN or put the participant at undue risk
  • Previously failed treatment with MMF or any form of mycophenolate-based induction therapy, based on the investigator's opinion
  • Use of complementary therapies, including Traditional Chinese Medicine, herbs, or procedure (eg, acupuncture) that can potentially interfere with the efficacy and safety of participants as assessed by the investigator
  • SARS-CoV-2 antigen-based positive test at screening. The test is required regardless of whether the participant has been vaccinated
  • Known hypersensitivity or contraindication to efgartigimod, any excipient of the IMP, or SoC medication used in the study
  • In the opinion of the investigator, current or history of (ie, within 12 months of randomization) alcohol, drug, or medication abuse
  • Pregnant or lactating females and those who intend to become pregnant during study participation
  • Any conditions or circumstances that in the opinion of the investigator may make the participant unsuitable for the study
  • The full list of criteria can be found in the protocol.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Peking University Third Hospital

    Beijing, 100191

  • Peking University People's Hospital

    Beijing

  • Hunan Provincial People's Hospital

    Changsha

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Fujian Medical University Union Hospital

    Fujian

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

  • The First Affiliated Hospital,Sun Yat-sen University

    Guanzhou

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou

  • First Affiliated Hospital of University of South China

    Hengyang

  • The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

    Huainan

  • Jieyang People's Hospital

    Jieyang, 522091

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan

  • Affiliated Hospital of Jining Medical University

    Jining

  • Liu Zhou Works Hospital

    Liuzhou

  • Jiangxi Provincial People's Hospital

    Nanchang, 330006

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Province Hospital

    Nanjing

  • Zhongda Hospital Southeast University

    Nanjing

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning

  • Huashan Hospital Fudan University

    Shanghai

  • ShengJing Hospital of China Medical University

    Shenyang

  • Shenzhen People's Hospital

    Shenzhen

  • The First Hospital of Hebei Medical University

    Shijia Zhuang

  • The Second Hospital of Tianjin Medical University

    Tianjin

  • Renmin Hospital of Wuhan University

    Wuhan

  • Wuxi People's Hospital

    Wuxi

  • Shaanxi Provincial Hospital of Chinese Medicine

    Xi'an

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 310058

  • Henan Provincial People's Hospital

    Zhengzhou

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis

The purpose of the study is to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN). The study comprises an approximate 4-week screening period, a 24-week treatment period, and an 8-week follow- up period.

Conditions
Lupus Nephritis
Being tested
efgartigimod IV, Placebo
Keywords
Nephritis, Lupus Nephritis, Kidney Disease, Urologic Disease, Glomerulonephritis
Medical subject headings
Lupus Nephritis, Nephritis, Kidney Diseases, Urologic Diseases, Glomerulonephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • efgartigimod IVBiological

    Intravenous (IV) infusion of efgartigimod

  • PlaceboOther

    Intravenous (IV) infusion of placebo

Study groups in NCT05810948
Study groupRoleWhat they receive
efgartigimod IVExperimentalPatients receiving intravenous (IV) infusions of efgartigimod
Receives: Biological: efgartigimod IV
PlaceboPlacebo comparatorPatients receiving intravenous (IV) infusions of placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to week 24 in urine protein creatinine ratio (UPCR)

    Measured: up to 24 weeks

Secondary outcomes (14)

  1. Proportion of participants achieving complete renal response (CRR) at week 24

    Measured: up to 24 weeks

  2. Time to complete renal response (CRR)

    Measured: up to 32 weeks

  3. Proportion of participants achieving partial renal response at week 24

    Measured: up to 24 weeks

  4. Time to partial renal response (PRR)

    Measured: up to 24 weeks

  5. Change from baseline to week 24 in estimated glomerular filtration rate (eGFR)

    Measured: up to 24 weeks

  6. Change from baseline to week 24 in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score

    Measured: up to 24 weeks

  7. Change from baseline to week 24 in the dosage of glucocorticoids

    Measured: up to 24 weeks

  8. Treatment failure rate during treatment period

    Measured: up to 24 weeks

  9. Proportion of participants achieving modified complete renal response (mCRR) at week 24

    Measured: up to 24 weeks

  10. Efgartigimod serum concentration-time profile

    Measured: up to 32 weeks

  11. Changes from baseline in levels of total IgG

    Measured: up to 32 weeks

  12. Incidence of ADA against efgartigimod

    Measured: up to 32 weeks

  13. Median changes in concentration from baseline over time in biomarkers (Anti-dsDNA, C3, C4 and CH50)

    (all have the same measuring units)

    Measured: up to 32 weeks

  14. Change from baseline to week 24 in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start21 Feb 2023
  3. Primary completion2 Jul 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05810948
Sponsor's protocol ID
ARGX-113-2202
Status last verified
Oct 2025
First submitted
19 Dec 2022
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing efgartigimod IV in people with Lupus Nephritis, run by argenx at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to week 24 in urine protein creatinine ratio (UPCR) (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05810948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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